This is a summary of the European public assessment report (EPAR) for Synflorix. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Synflorix. For practical information about using Synflorix, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
Active immunisation against invasive disease and acute otitis media caused by Streptococcus *pneumoniae* in infants and children from six weeks up to five years of age. See sections 4\.4 and 5\.1 in product information for information on protection against specific pneumococcal serotypes. The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.
Therapeutic Area (MeSH)
ATC Code
J07AL52
ATC Item
N/A
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Pneumococcal polysaccharide serotype 23F | N/A | Pneumococcal polysaccharide serotype 23F |
| Pneumococcal polysaccharide serotype 4 | N/A | Pneumococcal polysaccharide serotype 4 |
| Pneumococcal polysaccharide serotype 5 | N/A | Pneumococcal polysaccharide serotype 5 |
| Pneumococcal polysaccharide serotype 6B | N/A | Pneumococcal polysaccharide serotype 6B |
| Pneumococcal polysaccharide serotype 7F | N/A | Pneumococcal polysaccharide serotype 7F |
| Pneumococcal polysaccharide serotype 9V | N/A | Pneumococcal polysaccharide serotype 9V |
| Pneumococcal polysaccharide serotype 1 | N/A | Pneumococcal polysaccharide serotype 1 |
| Pneumococcal polysaccharide serotype 14 | N/A | Pneumococcal polysaccharide serotype 14 |
| Pneumococcal polysaccharide serotype 18C | N/A | Pneumococcal polysaccharide serotype 18C |
| Pneumococcal polysaccharide serotype 19F | N/A | Pneumococcal polysaccharide serotype 19F |
EMA Name
Synflorix
Medicine Name
Synflorix
Aliases
N/ANo risk management plan link.
